This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.

To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally. [ Time Frame: PK samples out to 96 hours after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing. ] [ Designated as safety issue: No ]

To obtain a preliminary assessment of the anti tumour activity of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1 [ Time Frame: Baseline assessment, then assessment every 6 weeks after start of treatment. ] [ Designated as safety issue: No ]

Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily

Experimental: Part C

Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A

Drug: AZD4547

Patients start at a dose of 80 mg twice daily, with no washout

Eligibility

Ages Eligible for Study:

25 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Minimum life expectancy of 12 weeks

The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist

In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification

Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study

An inability to be able to take the study medication

A bad reaction to AZD4547 or any drugs similar to it in structure or class.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979134